Devising a patent strategy to protect the IP of biologics in light of ambiguities, loopholes and pitfalls in the regulatory scheme

2013 ◽  
Vol 2 (2) ◽  
pp. 153-155
Author(s):  
Benjamin C Hsing ◽  
Sapna W Palla
Keyword(s):  
Regulatory Scheme ◽  
Patent Strategy

scholarly journals New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

2021 ◽  
Author(s):  
Nobuo Uemura ◽  
Hiroshi Kasanuki ◽  
Mitsuo Umezu
Keyword(s):  
The United States ◽  
New Combination ◽  
Biological Product ◽  
Regulatory Scheme ◽  
Early Access ◽  
Dimensional Group ◽  
Device Component ◽  
Intended Use ◽  
Component Function

Abstract Objective The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization. Method We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme. Results By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function. Conclusions The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.

Will rivals enter or wait outside when faced with litigation risk? Patent litigation in complex product industries and international market entry

2021 ◽  
pp. 147612702199825
Author(s):  
Ergun Onoz ◽  
Claudio Giachetti
Keyword(s):  
Market Entry ◽  
International Market ◽  
Joint Effect ◽  
Litigation Risk ◽  
Patent Litigation ◽  
Complex Product ◽  
Patent Strategy ◽  
Negative Effect ◽  
Rival Firms ◽  
The Relationship

A spiral of patent infringement litigation among rival firms is a phenomenon often observed in complex product industries, where products comprise numerous separately patentable elements. Theoretically grounded in the awareness–motivation–capability framework of competitive dynamics, this article contributes to the literature on patent strategy and international market entry by looking at how, in a complex product industry, the intensity of patent litigation in a country affects a firm’s decision to enter that country. Our results show that the intensity of patent litigation in a country is a deterrent for potential entrants and has a negative effect on a firm’s likelihood of entering that country. We also show that a firm’s previous experience with patent litigation ( awareness component), the share of a firm’s current patent applications in a target country ( motivation component), and the size of a firm’s patent stock ( capability component) moderate the relationship between a country’s patent litigation intensity and a firm’s likelihood of entering that country. We thus shed light on the joint effect of macro- and micro-level patent-related variables on a firm’s market entry decisions. We test our hypotheses with a comprehensive panel of patenting and entry strategies of 84 mobile phone vendors and their patent litigation battles in 45 countries, from 2003 to 2015.

The Uniform Status of Children of Assisted Conception Act: Does It Protect the Best Interests of the Child in a Surrogate Arrangement?

1990 ◽  
Vol 16 (4) ◽  
pp. 525-553
Author(s):  
Mimi Yoon
Keyword(s):  
Artificial Insemination ◽  
Medical Technology ◽  
Well Being ◽  
Best Interests ◽  
Medical Procedures ◽  
Assisted Conception ◽  
Regulatory Scheme ◽  
Infertile Couples ◽  
Definition Of

Medical technology is easing the plight of many infertile couples by offering such reproductive alternatives as in vitro fertilization, artificial insemination and surrogacy. In response to the changes in our society's definition of family, wrought by scientific advances, the National Conference of Commissioners on Uniform States Laws promulgated the Uniform Status of Children of Assisted Conception Act. The purpose of this Act is to protect the interests of children born through extraordinary medical procedures. This Note analyzes the Act's provisions regarding surrogacy and focuses on how the Commission's regulatory scheme fails to protect the child's interests. The Act's alternative of voiding the surrogacy contract also does not protect the child's interests. A more complete regulatory scheme which protects the adult parties’ interests, as well as the child's, should be devised, as the adequacy of the adult parties’ protection ultimately affects the child's well-being.

Patent strategy in Chinese universities: a comparative perspective

2010 ◽  
Vol 84 (1) ◽  
pp. 53-63 ◽  
Author(s):  
Chunjuan Luan ◽  
Chunyan Zhou ◽  
Aiyun Liu
Keyword(s):  
Comparative Perspective ◽  
Chinese Universities ◽  
Patent Strategy

Patent management: the prominent role of strategy and organization

2022 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Lara Agostini ◽  
Anna Nosella ◽  
Marcus Holgersson
Keyword(s):  
Survey Study ◽  
European Patent ◽  
Content Type ◽  
Quantitative Evidence ◽  
Patent Strategy ◽  
Organizational Perspective ◽  
The Impact ◽  
Patent Management ◽  
Patent Portfolio

PurposeThe purpose of this article is twofold; to verify the existence of different profiles of firms based on the level of sophistication of their patent management core processes and to test the impact of the interplay between two patent management supporting dimensions, namely patent strategy and organization for patenting, on the level of sophistication of patent management core processes.Design/methodology/approachThe method consists of a survey study, collecting data from a set of European patent management professionals. These data are analyzed with factor analysis, cluster analysis and regression analysis to test several hypotheses.FindingsThe results show that patent strategy positively and significantly impacts patent management sophistication, and that the patent organization positively moderates this relationship. In other words, a patent strategy, supported by a well-developed patent organization and culture, will positively influence the processes of managing a firm's patent portfolio.Originality/valueThis study is, to the authors’ knowledge, the first one to provide quantitative evidence that supports the notion that it is important to take a strategic and organizational perspective of patent management.

Epilogue

2020 ◽  
pp. 264-270
Author(s):  
Arzoo Osanloo
Keyword(s):  
Death Penalty ◽  
Legal System ◽  
Crucial Role ◽  
Differential Treatment ◽  
Human Right ◽  
Social Field ◽  
Regulatory Scheme ◽  
Bureaucratic State

This epilogue looks at the modern bureaucratic state. It considers what it means for a state's regulatory scheme to be comprised of such a range of free-roaming and diverse actors who operate in a semi-autonomous social field and participate in shaping and regulating its operations. Consequently, the epilogue reflects on what forgiveness work means for rights, law, and the higher aims of the Qur'anic mandate of mercy. Mercy means a lessening of deserved punishment (leniency) and, at the same time, mercy's very presence suggests injustice lies everywhere. That is, where there is mercy, there is injustice. However, mercy can play a crucial role in bringing about justice. The insistence on mercy, even if it is a power from above, can offer a crucial corrective to injustice. In some ways, this feature of the legal system explains the involvement of government agents in forgiveness work and suggests the basis for the state's differential treatment of anti-death penalty or human right activists versus forgiveness workers.

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